Quality Management Systems

Experienced Quality Management System Reviews and Development

One of the most difficult challenges for pharmaceutical, biotech, and medical device manufacturers is maintaining quality systems compliance with the little “c” in cGMP. Staying current with regulations, industry standards, and customer expectations is an ongoing continuum—a continuum of understanding your processes, learning from them, and reapplying that knowledge back into the process. A once compliant quality system can become obsolete or ineffective over time, and with nearly two decades of experience, we have found that the investment dedicated to updating a dated system will be only a fraction of the investment required when that same system fails.

With solutions catered for both start-up firms and established companies, ProPharma Group is capable of supporting your organization’s unique needs. Start-up firms come to ProPharma Group to develop quality management systems that include policies and standard operating procedures (SOPs) necessary to implement the framework of their quality program. With a firm understanding of development company’s positions in the lifecycle, we implement QMS systems that are appropriate for the stage of development and build accordingly. Established companies utilize ProPharma Group to help them optimize their procedures to reflect best industry practice or regulatory expectations.